Events

Recall of ACCESS SYSTEM - IL6 (INTERLUKEN6)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25902
  • Event Risk Class
    III
  • Event Initiated Date
    2015-10-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Beckman coulter has determined through internal testing that access il-6 calibrator lot 217782 has failed to meet its stability specifications and expiration dating. access il-6 calibrator lot 217782 may generate falsely elevated patient sample and quality control results across the reportable assay range. based on internal testing the customer may experience patient sample and quality control results approximately 15% higher than the corresponding values observed in baseline testing against this calibrator lot. the issue was discovered through internal testing in april 2015. there has been no report of death or injury related to this issue.

Device

ACCESS SYSTEM - IL6 (INTERLUKEN6)
  • Model / Serial
    Model Catalog: A16370 (Lot serial: 217782)
  • Product Description
    Access IL-6 Calibrators
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.